Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-16 @ 3:39 PM
Study NCT ID:
NCT03655093
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2018-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-29', 'studyFirstSubmitDate': '2018-08-29', 'studyFirstSubmitQcDate': '2018-08-29', 'lastUpdatePostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validate the French version of the AMSQ self-questionnaire in a population of MS patients', 'timeFrame': 'At inclusion', 'description': 'Evaluate item fit of the French version of the AMSQ using the graded response model, developed by Samejima (cf. reference)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Self-questionnaire', 'Measurement tools'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Samejima F. Estimation of latent ability using a response pattern of graded scores. Richmond, VA: The Psychometric Society, 1969.'}]}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system that causes disability in young adults. This disability can take many forms depending on the neurological systems affected: disability walking, cognitive impairment or disability in the upper limbs. The development of validated measurement tools for these different disabilities is essential for the follow-up of patients in clinical routine and for the evaluation of new therapies.', 'detailedDescription': 'A specific self-questionnaire for patients with MS has recently been developed and validated in English and Dutch: "The Arm Function in Multiple Sclerosis Questionnaire (AMSQ)". The questionnaire groups 31 items and was created from questionnaires developed for other pathologies. The Dutch team that developed this questionnaire combines biostatisticians and neurologists, experts in the development and validation of disability measurement tools.\n\nThis study aims to validate the French version of AMSQ questionnaire. This study is carried out in collaboration with the Amsterdam team, which has carried out the methodology and will conduct the statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with MS according to the diagnostic criteria of 2010', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with MS according to the diagnostic criteria of 2010\n* Age ≥18 years\n* Patients seen in consultation at the SEP reference center in Rennes\n\nExclusion Criteria:\n\n* Other neurological or rheumatological pathology hindering the use of the upper limbs\n* Inability to understand\n* Minors\n* Major persons subject to legal protection (legal safeguards, guardianship)\n* Persons deprived of their liberty'}, 'identificationModule': {'nctId': 'NCT03655093', 'acronym': 'MS-SEP', 'briefTitle': 'Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '35RC17_3063'}, 'secondaryIdInfos': [{'id': '2017-A00788-45', 'type': 'OTHER', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with multiple sclerosis', 'description': 'Patients with MS according to the diagnostic criteria of 2010 Validation of AMSQ questionnaire', 'interventionNames': ['Other: Validation of AMSQ questionnaire']}], 'interventions': [{'name': 'Validation of AMSQ questionnaire', 'type': 'OTHER', 'description': "Participation in the study will be proposed to any patient meeting the inclusion criteria and consulting a neurologist from the SEP reference center of the University Hospital of Rennes.\n\nThe neurologist will explain the purpose of the study to the patient, give him the information form.\n\nWithout opposition from the patient, the neurologist will give him the self-questionnaire. The patient will fill it during the consultation. In case of disability to the upper limbs making it impossible to fill the questionnaire by the patient, it will be filled by the neurologist or the patient's companion, according to the answers given by the patient.\n\nWhile the patient completes the questionnaire, a record of clinical information will be filled in by the neurologist.\n\nNo additional act will be performed except the questionnaire, which result will not change the patient's management.", 'armGroupLabels': ['Patients with multiple sclerosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Rennes University Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Anne Kerbrat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}